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London: Monday, March 7, 2016: The announcement below is a repeat of RNS No. 1732R originally released on Friday, March 4, 2016 at 17:54 hours GMT.
London: Friday, March 4, 2016: Further to its announcements on October 16, 2015, November 13, 2015, February 11, 2016 and March 1, 2016, Hutchison China MediTech Limited (“Chi Med”) (AIM: HCM) announces that today it publicly filed a fifth draft of the registration statement on Form F-1 (the “Form F-1 Registration Statement”) with the United States Securities and Exchange Commission (the “SEC”) in relation to a potential listing of American depositary shares (“ADSs”) representing its Ordinary Shares on the Nasdaq Stock Market (the “Offering”). The directors of Chi-Med (the “Directors”) believe that a listing in the United States would allow Chi-Med to raise its profile in the U.S. pharmaceutical market, the world’s largest, and increase its recognition amongst the large number of specialist healthcare investors in the United States, thereby potentially resulting in additional trading liquidity.
Chi-Med intends to raise, subject to market and other conditions, approximately US$100.0 million in gross proceeds from the Offering. Based on the closing price of the shares of Chi-Med on AIM on March 3, 2016 of £23.50 per Ordinary Share, 6,123,698 ADSs are expected to be sold by Chi-Med for US$16.33 per ADS (on the basis of each ADS representing one-half of one Ordinary Share and an assumed exchange rate of £1.00 to US$1.39). The closing price on AIM on October 15, 2015, which was the date immediately prior to the first publicly filed Form F-1 Registration Statement, was £19.33 per Ordinary Share. The final price per ADS placed in the potential Offering will be determined following the book-building process and as such, the number of ADSs to be sold may change.
Mr Simon To, Chairman of Chi-Med, said, “We believe that a dual listing on the Nasdaq Stock Market provides the right platform for Chi-Med, as it opens up a new and deep universe of biopharmaceutical investors and analysts.”
Chi-Med will grant the underwriters a 30-day option to purchase up to an additional 918,554 ADSs at the offering price. Chi-Med has applied to have its ADSs approved for listing on the Nasdaq Stock Market under the symbol “HCM.”
In addition to the net proceeds which may be generated by the Offering, Chi-Med plans to continue to utilize its various resources, including existing cash and cash equivalents, short-term investments, credit facilities, expected cash flow from operations and cash compensation from the surrender of land use rights, to pursue the current research and development plans for its drug candidates. Although the final size of the proposed Offering may be subject to change, Chi-Med intends to use the net proceeds of the proposed Offering, together with the cash generated from operations and such other cash resources, primarily to further advance the clinical development of its multiple drug candidates. In particular, Chi-Med expects to apply these estimated net proceeds as follows:
a) approximately US$41.0 million to accelerate and broaden clinical development of the drug candidates for which it retains all worldwide rights, specifically:
i. approximately US$20.0 million to advance HMPL-523 through Phase I and into Proof-of-Concept studies, expected to be conducted in Australia, the United States and China, in rheumatoid arthritis, lupus and hematological cancer;
ii. approximately US$12.0 million to advance sulfatinib toward NDA submission in China as well as through Phase I and into Proof-of-Concept studies, expected to be conducted in the United States, in neuroendocrine tumors and through Phase II and into Proof-of-Concept studies, expected to be conducted in China, in thyroid cancer;
iii. approximately US$7.0 million to advance epitinib into a Phase III registration in China and through Phase I and into Proof-of-Concept studies, expected to be conducted in the United States, in non-small cell lung cancer with brain metastasis; and
iv. approximately US$2.0 million to advance theliatinib through Phase I and into Proof-of-Concept studies, expected to be conducted in China, in head and neck cancer and esophageal cancer;
b) approximately US$27.0 million to support its share of the development costs of its partnered clinical drug candidates, including:
i. approximately US$12.0 million to advance savolitinib through NDA submission globally in papillary renal cell carcinoma and EGFR tyrosine kinase inhibitor-refractory non-small cell lung cancer and through Proof-of-Concept studies in gastric cancer and VEGFR tyrosine kinase inhibitor-refractory clear cell renal cell carcinoma;
ii. approximately US$10.0 million to advance fruquintinib through NDA submission in colorectal cancer and non-small cell lung cancer in China and through Proof-of-Concept in gastric cancer in China and to advance fruquintinib into Proof-of-Concept studies in non-small cell lung cancer and/or other solid tumor indications in the United States either independently or in partnership with Eli Lilly subject to the exercise of its global option;
iii. approximately US$5.0 million to advance either existing or new formulations of HMPL-004 into clinical development in mild-to-moderate ulcerative colitis;
c) approximately US$11.0 million to progress pre-clinical drug candidates, specifically:
i. approximately US$4.0 million to advance HMPL-689 through Phase I and into Proof-of-Concept studies, expected to be conducted in Australia, the United States and China, in hematological cancer;
ii. approximately US$4.0 million to advance HMPL-453 through Phase I and into Proof-of-Concept studies, expected to be conducted in Australia, the United States and China, in bladder cancer; and
iii. approximately US$3.0 million to advance other drug candidates through pre-clinical studies and into Phase I clinical trials; and
d) approximately US$5.0 million to build production facilities to produce both clinical and commercial supply of its drug candidates.
The expected usage of the proposed net proceeds of the Offering represents intentions of the Directors based upon their current plans and Chi-Med’s business conditions, which could change in their discretion in the future as their plans and Chi-Med’s business conditions evolve. Due to the many variables inherent in the development of its drug candidates at this time, such as the timing of patient enrollment and evolving regulatory requirements, the Directors cannot currently predict the stage of development they expect to achieve for Chi-Med’s pre-clinical and clinical trial and drug candidates with the net proceeds of the proposed Offering. Chi-Med expects to use the remainder of the net proceeds to provide funding for working capital and other general corporate purposes, such as acquiring the commercial rights to other drug products and expanding its research organization and infrastructure.
The amounts and timings of the actual expenditure to be incurred by Chi-Med may vary significantly depending on numerous factors, including the results of the pre-clinical and clinical trial of its drug candidates, its operating costs and expenditures and the amount of cash generated by its operations. Accordingly, the Directors will have broad discretion over the usage of the net proceeds. Pending these uses, the Directors intend to invest these net proceeds in high-quality, investment-grade, short-term fixed income instruments.
BofA Merrill Lynch and Deutsche Bank Securities (in alphabetical order) are acting as joint global coordinators and joint bookrunners for the potential Offering. Stifel, Canaccord Genuity, Panmure Gordon & Co. and CITIC CLSA are acting as co-managers for the potential Offering.
The Form F-1 Registration Statement relating to the ADSs has been filed with the SEC but has not yet become effective. The ADSs may not be sold, nor may offers to buy be accepted, prior to the time the Form F-1 Registration Statement becomes effective. The Form F-1 Registration Statement and all subsequent amendments may be accessed through the SEC’s website at www.sec.gov.
The potential Offering will be made only by means of a prospectus that will form part of the effective Form F-1 Registration Statement. Copies of the preliminary prospectus may be obtained from (in alphabetical order) (i) BofA Merrill Lynch, Attn: Prospectus Department, 222 Broadway, New York, NY 10038, or by email at email@example.com, or (ii) Deutsche Bank Securities Inc., Attn: Prospectus Group, 60 Wall Street, New York, NY 10005, or by email at firstname.lastname@example.org.
This announcement does not constitute an offer to sell or the solicitation of an offer to buy ADSs or any other securities, nor shall there be any sale of ADSs in any state or jurisdiction in which such an offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.
Shareholders and potential investors should note that the potential Offering may or may not proceed, and accordingly are advised to exercise caution when dealing in the securities of Chi-Med.
Telephone: +852 2121 8200
Christian Hogg, CEO
Panmure Gordon (UK) Limited
Telephone: +44 20 7886 2500
Citigate Dewe Rogerson
Telephone: +44 20 7638 9571
Mobile: +44 7973 611 888
Mobile: +44 7967 566 919
Chi-Med is a China-based, globally-focused healthcare group which researches, develops, manufactures and sells pharmaceuticals and health-related consumer products. Its Innovation Platform focuses on discovering and developing innovative therapeutics in oncology and autoimmune diseases for the global market. Its Commercial Platform manufactures, markets and distributes prescription drugs and consumer health products in China.
Chi-Med is majority owned by the multinational conglomerate CK Hutchison Holdings Limited (SEHK: 0001). For more information, please visit: www.chi-med.com.
This announcement does not constitute a registration statement on Form F 1 and does not constitute or form, and will not form, part of any offer or invitation to sell or issue, or the solicitation of an offer to purchase or acquire, any of the Ordinary Shares or ADSs or any other securities in the United States or in any other jurisdiction. Securities may not be offered or sold in the United States absent registration or an exemption from registration under the United States Securities Act of 1933, as amended (“U.S. Securities Act”). Any potential public offering of securities to be made in the United States will be made by means of a Form F 1 Registration Statement that has been declared effective by the SEC. The Form F 1 Registration Statement contains detailed information about the issuer and its management and financial statements. This announcement is being issued pursuant to and in accordance with Rule 135e under the U.S. Securities Act.
No money, securities or other consideration is being solicited, and, if sent in response to the information contained in this announcement, will not be accepted.
This announcement is not directed to, or intended for distribution or use by, any person or entity that is a citizen or resident or located in any locality, state, country or other jurisdiction where such distribution, publication, availability or use would be contrary to law or regulation or which would require any registration or licensing within such jurisdiction.
The distribution of this announcement into jurisdictions other than the United Kingdom may be restricted by law. Persons into whose possession this announcement come should acquaint themselves with and observe any such restrictions.
In any EEA Member State that has implemented the Prospectus Directive, this announcement is only addressed to and directed at qualified investors in that Member State within the meaning of the Prospectus Directive. The term “Prospectus Directive” means Directive 2003/71/EC (and amendments thereto, including Directive 2010/73/EU, to the extent implemented in each relevant Member State), together with any relevant implementing measure in the relevant Member State.
This announcement, insofar as it constitutes an invitation or inducement to enter into investment activity (within the meaning of section 21 of the Financial Services and Markets Act 2000, as amended) in connection with the securities which are the subject of the potential Offering described in this announcement or otherwise, is being directed only at (i) persons who are outside the United Kingdom; or (ii) persons who have professional experience in matters relating to investments who fall within Article 19(5) (investment professionals) of the Financial Services and Markets Act 2000 (Financial Promotion) Order 2005 (“Order”); or (iii) certain high value persons and entities who fall within Article 49(2)(a) to (d) (high net worth companies, unincorporated associations etc) of the Order; or (iv) any other person to whom it may lawfully be communicated (all such persons in (i) to (iv) together being referred to as “relevant persons”). The ADSs are only available to, and any invitation, offer or agreement to subscribe for, purchase or otherwise acquire such ADSs will be engaged in only with, relevant persons. Any person who is not a relevant person should not act or rely on this announcement or any of its contents.
This announcement may contain forward looking statements that reflect Chi Med’s current expectations regarding future events, including completion of the potential Offering. A list and description of risks, uncertainties and other risks associated with an investment in Chi Med can be found in Chi Med’s filings with the SEC, including the Form F 1 Registration Statement. Existing and prospective investors are cautioned not to place undue reliance on these forward looking statements, which speak only as of the date hereof. Chi Med undertakes no obligation to update or revise the information contained in this announcement, whether as a result of new information, future events or circumstances or otherwise.
For the purposes of this announcement:
“EGFR” means epidermal growth factor receptor;
“NDA submission” means a request for approval to market a drug containing evidence of safety and efficacy which is demonstrated by extensive pre-clinical and clinical testing;
“Ordinary Shares” means the fully paid ordinary shares in the capital of Chi-Med which have a nominal value of US$1 each, and “Ordinary Share” means any one of them;
“Phase I” means a preliminary clinical trial for clinical pharmacology and body safety, conducted to observe the human body tolerance for new medicine and pharmacokinetics, so as to provide a basis for determining the prescription plan;
“Phase II” means a stage of preliminary evaluation of clinical effectiveness, the purpose of which is to preliminarily evaluate the clinical effectiveness and safety of the medicine used on patients with targeted indication, as well as to provide a basis for determining the Phase III clinical trial research plan and the volume under the prescription plan;
“Phase III” means a clinical trial stage to verify the clinical effectiveness, the purpose of which is to test and determine the clinical effectiveness and safety of the medicine used on patients with targeted indication, to evaluate the benefits and risks thereof and, eventually, to provide sufficient basis for review of the medicine registration application;
“Proof-of-Concept” means a clinical trial conducted to establish the clinical effectiveness and safety of the new medicine used on patients with the targeted indication. Generally Proof-of-Concept trials are categorized as either Phase Ib or Phase II trials, which are clinical trials conducted in a larger patient population than for a Phase I trial, but in a smaller patient populations than Phase III registration application trials; and
“VEGFR” means vascular endothelial growth factor receptor.